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Disposable Sterile Lancet: The lancet is intended for capillary blood sampling.

Lancing Device:

The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is single patient use only and should not be shared with anyone else, even a family member.

Disposable Sterile Lancet is Class II Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature bearing the product code ORK (21CFR 878.4850), and The Disposable Sterile Lancet and lancing device is Class II Multiple Use Blood Lancet For Single Patient Use Only bearing the product code QRL (21CFR878.4850).

The lancet is for single use, disposable sterile devices, which is designed to collect capillary blood samples. And the lancing device is intended for capillary blood sampling with Disposable Sterile Lancet. The lancet can be used independently, or used together with lancing device.

The intended users include healthcare personnel, patients and lay users.

The lancet is provided sterile. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf life of the lancet is 5 years.

This document describes a 510(k) submission for a Disposable Sterile Lancet and Lancing Device. The submission aims to demonstrate substantial equivalence to a predicate device (K220475).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the non-clinical performance and biocompatibility tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies conducted are non-clinical (performance and biocompatibility), which do not typically involve human expert ground truth establishment in the same way clinical studies or AI diagnostic device studies would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. The studies are non-clinical laboratory tests, not clinical evaluations requiring adjudication of expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (lancet and lancing device), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical device. There is no algorithm or AI component involved.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests was established by objective measurements and standardized testing procedures against defined acceptance criteria (e.g., measuring puncture force, examining appearance for defects, confirming sterility via standard methods, and conducting biocompatibility tests according to ISO standards). It's essentially objective laboratory measurements and adherence to international standards.

8. The sample size for the training set

This is not applicable as there is no mention of a training set. This is a traditional medical device submission, not an AI/machine learning device that requires training data.

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this type of device.

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It is intended for capillary blood sampling.

Disposable Sterile Lancet is Class II Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature bearing the product code FMK (21CFR878.4850). The lancet is for single use, disposable sterile devices, which is designed to collect capillary blood samples. The Disposable Sterile Lancet consist of protective cap, housing, bottom, fire button, connection ring, springs (ejection spring and fire spring), and core of lancet (including needle). The sterile part of the lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf life of the product is 5 years.

The provided text is a 510(k) summary for a Disposable Sterile Lancet. It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

Based on the information provided, here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them:

Device: Disposable Sterile Lancet
Intended Use: Capillary blood sampling.

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes for each non-clinical test conducted. It generally refers to "tests" and "results" without specifying the number of units tested.
The data provenance is the manufacturer, Tianjin Rilifine Medical Device Co., Ltd., based in China. The study is a non-clinical study (laboratory testing) rather than a clinical study involving human patients, and therefore, the terms "retrospective" or "prospective" are not directly applicable in the same way they would be for patient data. It is a series of tests performed on the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not mention the use of experts to establish "ground truth" for the non-clinical tests. These tests are based on objective measurements and established standards (e.g., ISO standards) rather than subjective expert consensus. For example, sterility is tested to a SAL of 10^-6, not determined by expert opinion.

4. Adjudication Method for the Test Set

Not applicable. As these are non-clinical, objective tests against pre-defined acceptance criteria (often tied to ISO standards), there is no mention of an adjudication method by multiple experts. The results are binary (meets/does not meet requirements, pass/fail).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/image analysis devices where human readers interpret diagnostic images, and the AI assists in that interpretation. The Disposable Sterile Lancet is a physical medical device for blood sampling, and its performance is evaluated through physical and biological testing, not by human reader interpretation of data in a comparative effectiveness study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device. The performance evaluated is the physical function and material properties of the lancet itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective measurements against predefined specifications and recognized international standards. For example:

• Dimensions: Comparison to engineering drawings.
• Sterility: Adherence to ISO 11137 standards for a SAL of 10^-6.
• Biocompatibility: Adherence to ISO 10993 standards (e.g., non-cytotoxic, non-irritating, non-sensitizing).
• Functional Performance (Puncture Depth, Launch Performance, Firmness): Measured against internal design specifications and simulated real-world use (e.g., A4 paper for puncture depth, observation of retraction).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The testing described is for a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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